Optimizing Postoperative Recovery After Breast Reconstruction With Autologous Tissue (BestDIEP) (BestDIEP)

August 7, 2023 updated by: Vastra Gotaland Region
Women who have their breast reconstructed with autologous tissue seem to be more satisfied with their breast. However, autologous breast reconstruction entails a bigger operation, and the usage of more health care resources, than some other methods, such as implant-based techniques. The main objectives of the present study are to investigate if pre- peri- and postoperative protocols can be safely modified, so the operation demands less resources, while maintaining a low complication rate and a high patient satisfaction.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

380

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Sweden
      • Gothenburg, Sweden, 413 45
        • Recruiting
        • Sahlgrenska University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Biological women undergoing breast reconstruction with a deep inferior epigastric artery perforator flap in Sahlgrenska university hospital.

Description

Inclusion Criteria:

  • Operated or will be operated with a DIEP flap in the department
  • >18 years of age

Exclusion Criteria:

  • Inability to leave informed consent
  • Inability to understand and speak Swedish (for the questionnaire)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
No venons augmentation
Retrospective group of patients who have not received venous augmentation during their operation.
Procedure: No venous augmentation
Traditional deep inferior epigastric artery perforator flap (DIEP)
Venous augmentation
Retrospective group of patients who have received venous augmentation during their operation.
Procedure: Venous augmentation
Increasing the venous drainage of a deep inferior epigastric artery perforator (DIEP) flap by anastomosing the superficial inferior epigastric vein to the cephalic vein
Other Names:
  • Double venous system drainage
  • Cephalic vein turndown
ERAS protocol
Retrospective group operated according to the traditional ERAS (enhanced recovery after surgery) protocol
Procedure: Traditional ERAS (enhanced recovery after surgery) protocol
Pre-, peri-, and post-operative care as described in the ERAS protocol
Sahlgrenska recovery protocol
Prospective group operated according to the Sahlgrenska recovery protocol.
Procedure: Sahlgrenska recovery protocol
Pre-, peri-, and post-operative care as described in the Sahlgrenska recovery protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Re-operations
Time Frame: 7 days
Any re-operations performed for any cause during the first 7 days after the operation
7 days
Length of stay (LOS) in hospital
Time Frame: 7 days
Number of days the patient stays in the hospital after the operation
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient reported satisfaction and quality of life
Time Frame: 12 months
Measured with BREAST-Q reconstruction. The patient scores different items om a scale and a sum score of 0-100 is calculated for each domain. A higher score indicates a higher satisfaction/quality of life.
12 months
Surgical corrections
Time Frame: 5 years
Number of cosmetic corrections. All types of corrections performed in general or local anesthetics will be included.
5 years
Costs
Time Frame: 5 years
Health economical analysis of direct and indirect cost related to the different protocols
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vastra Gotaland Region

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2022

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

May 2, 2022

First Submitted That Met QC Criteria

May 2, 2022

First Posted (Actual)

May 5, 2022

Study Record Updates

Last Update Posted (Actual)

August 8, 2023

Last Update Submitted That Met QC Criteria

August 7, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2022-01423-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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